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Patent 2366708 Summary

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(12) Patent Application: (11) CA 2366708
(54) English Title: LOW PROFILE ANASTOMOSIS CONNECTOR
(54) French Title: RACCORD D'ANASTOMOSE BAS PROFIL
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61B 17/08 (2006.01)
(72) Inventors :
  • LOSHAKOVE, AMIR (Israel)
  • KILEMNIK, IDO (Israel)
  • KEREN, DVIR (Israel)
  • ZIMET, NACHMAN (Israel)
(73) Owners :
  • BY-PASS, INC. (United States of America)
(71) Applicants :
  • BY-PASS, INC. (United States of America)
(74) Agent: MCCARTHY TETRAULT LLP
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 2000-03-20
(87) Open to Public Inspection: 2000-09-28
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/IB2000/000310
(87) International Publication Number: WO2000/056228
(85) National Entry: 2001-09-13

(30) Application Priority Data:
Application No. Country/Territory Date
129067 Israel 1999-03-19
PCT/IL99/00284 Israel 1999-05-30
PCT/IL99/00285 Israel 1999-05-30
PCT/IL99/00670 Israel 1999-12-08
PCT/IL99/00674 Israel 1999-12-09

Abstracts

English Abstract




An anastomosis connector comprises a plurality of ring segments (106),
together defining a radially expandable ring-like shape (106) having a lumen;
at least one pivot bar (114) coupled to at least one of said ring segments
(106); at least one spike (109) mounted on said pivot bar (114) and rotatable
around said pivot bar (114), wherein radial deformation of said ring-like
shape (106) does not substantially directly affect said spike (109) rotational
position.


French Abstract

L'invention concerne un raccord d'anastomose comprenant une pluralité de segments (106) annulaires, définissant une configuration (106) annulaire se dilatant radialement et présentant une lumière; au moins une tige (114) d'articulation couplée à au moins un des segments (106) annulaires; au moins une pointe (109) verticale montée sur la tige (114) d'articulation et tournant autour de cette dernière (114). La déformation radiale de la configuration (106) annulaire n'affectant pratiquement pas la position rotative de la pointe (109) verticale.

Claims

Note: Claims are shown in the official language in which they were submitted.



CLAIMS
1. An anastomosis connector, comprising:
a plurality of ring segments, together defining a radially expandable ring-
like shape
having a lumen;
at least one pivot bar coupled to at least one of said ring segments; and
at least one spike mounted on said pivot bar and rotatable around said pivot
bar,
wherein radial deformation of said ring-like shape does not substantially
directly affect
said spike rotational position.
2. A connector according to claim 1, wherein rotation of the pivot bar is
mechanically
decoupled from radial deformation of ring-like shape.
3. A connector according to claim 2, wherein said at least one pivot bar
comprises at leas
two pivot bars, wherein said at least one spike is mounted on a first one of
said pivot bars and
said first pivot bar is mounted on the other pivot bar.
4. A connector according to claim 1, wherein said at least one spike is
pointed towards
said ring-like shape.
5. A connector according to claim 1, wherein said at least one spike is
pointed away from
said ring-like shape.
6. A connector according to claim 1, wherein said at least one spike comprises
at least
two spikes, each mounted on a separate pivot bar, wherein said spikes point in
opposite
directions along an axis of said connector.
7. A connector according to claim 1, wherein said connector is designed such
that said at
least one spike remains outside of a side vessel in an end-to-side
anastomosis.
8. A connector according to claim 1, wherein said connector is designed such
that said at
least one spike enters a side vessel in an end-to-side anastomosis.
22


9. A connector according to claim 1, wherein said pivot bar is comprised in a
spike
element.
10. A connector according to claim 9, wherein said spike element comprises two
opposing
spikes.
11. A connector according to claim 9, wherein said spike element interconnects
two
adjacent ring segments.
12. A connector according to claim 9, wherein said spike element is attached
to only a
single ring element.
13. A connector according to claim 1, wherein said at least one spike has a
tip adapted to
penetrate a blood vessel.
14. A connector according to claim 1, wherein said at least one spike has a
tip adapted to
lay against a blood vessel without penetrating it.
15. A connector according to claim 1, wherein said connector is heat-treated
to have said at
least one spike perpendicular to said ring.
16. A connector according to claim 1, wherein said connector is heat-treated
to have said at
least one spike parallel to said ring.
17. A connector according to claim 1, wherein said connector is heat-treated
to have said at
least one spike bend.
18. A connector according to claim 1, wherein said connector is heat-treated
such that said
at least one spike does not bend.
19. A connector according to claim 1, wherein said connector is heat-treated
such that said
pivot bar is twisted.
23


20. A connector according to claim 1, wherein said connector is heat-treated
such that said
pivot bar is not twisted.
21. A connector according to claim 1, wherein said pivot bar is within an
axial extent of
said ring-like shape.
22. A connector according to claim 21, wherein said pivot bar is substantially
centered
relative to said ring like shape.
23. A connector according to claim 1, wherein said pivot bar is outside an
axial extent of
said ring-like shape.
24. A connector according to claim 1, wherein said pivot bar is comprised in a
pivot
mechanism.
25. A connector according to claim 24, wherein said pivot mechanism is
directly mounted
onto at least one of said ring elements.
26. A connector according to claim 24, wherein said pivot mechanism is coupled
via a
single extension to at least one of said ring elements.
27. A connector according to claim 24, wherein said pivot mechanism is coupled
via at
least two extensions to at least one of said ring elements.
28. A connector according to claim 24, wherein said pivot bar is coupled to
said pivot
mechanism via a hinge at each end of said pivot bar.
29. A connector according to claim 28, wherein said hinge comprises a
thickening of said
mechanism relative to said pivot bar.
30. A connector according to claim 24, wherein said connector comprises a
plurality of
alternating ring segments and pivot bar mechanism and wherein said pivot bar
mechanisms are
axially staggered, to allow a greater radial compression of said ring-like
shape.
24



31. A connector according to claim 1, wherein said pivot bar is straight.
32. A connector according to claim 1, wherein said pivot bar is piece-wise
straight.
33. A connector according to claim 1, wherein said pivot bar is curved.
34. A connector according to claim 1, wherein said connector is packaged.
35. A connector according to claim 34, wherein said packaging indicates a
particular vessel
type for said connector and for which said connector is adapted.
36. A connector according to claim 35, wherein said vessel type comprises a
femoral
artery.
37. A connector according to claim 35, wherein said vessel type comprises an
aorta.
38. A connector according to claim 34, wherein said packaging indicates a
particular vessel
size for said connector and for which said connector is adapted.
39. A connector according to claim 34, wherein said packaging indicates a
particular vessel
wall thickness for said connector and for which said connector is adapted.
40. A connector according to claim 39, wherein said ring-like shape has an
axial extent
smaller than said wall thickness.
41. A connector according to claim 34, wherein said packaging indicates a
particular
connection geometry for said connector and for which said connector is
adapted.
42. A connector according to claim 41, wherein said geometry is a side-to-end
geometry.
43. A connector according to claim 34, wherein said packaging indicates a
particular
oblique angle geometry for said connector and for which said connector is
adapted.
25


44. A connector according to claim 1, wherein said at least one spike is cut
out of an
opposing spike of said connector.
45. A connector according to claim 1, wherein at least one of said ring
segments comprises
a plurality of axially spaced elements.
46. A connector according to claim 45, wherein said plurality of elements
comprises at
least three elements.
47. A connector according to claim 45, wherein said plurality of elements
comprises at
least four elements.
48. A connector according to claim 45, wherein said plurality of elements
comprises at
least five elements.
49. A connector according to claim 45, wherein all of said plurality of
elements have a
same geometry.
50. A connector according to claim 45, wherein at least two of said plurality
of elements
have mirrored geometries.
51. A connector according to claim 45, wherein at least one of said plurality
of elements
has a single curve geometry.
52. A connector according to claim 45, wherein at least one of said plurality
of elements
has a dual curve geometry.
53. A connector according to claim 45, wherein at least one of said plurality
of elements
has at least three curves defined thereby.
54. A connector according to claim 45, wherein at least one of said plurality
of elements
has a varying width.
26


55. A connector according to claim 45, wherein all of said phu~~
constant width.
56. A connect or according to claim 45, comprising a strain dissipation
element at a point of
connection of at least one of said elements and a spike element to which said
ring segment is
attached.
57. A connector according to claim 56, wherein said strain dissipation element
comprises a
thickening of said axially spaced element.
58. A connector according to claim 57, wherein said thickening defines an
aperture.
59. A method of everting a blood vessel, comprising:
engaging a tip of said vessel at a plurality of points around its
circumference;
inverting said tip by inverting said points; and
pulling said inverted points towards a distal end of said blood vessel.
60. A method according to claim 59, wherein said plurality comprises at least
four points.
61. A method according to claim 59, wherein said engaging comprises engaging
using
forceps and wherein said inverting comprises rotating said forceps.
62. A method according to any of claims 59-61, wherein said pulling comprises
pulling
different ones of said points different amounts.
63. Apparatus for graft eversion of a graft over a shaft having a tip,
comprising:
a handle for engaging said shaft;
a plurality of forceps arranged to engage a tip of said graft where it
protrudes form said
shaft; and
a plurality of joints, each one associated with one of said forceps, for
rotating said
forceps pulling a tip of each of said forceps axially along said shaft.
64. A method of measuring a graft size, comprising:
27


mounting a tip of said graft on two extensions, one extensions, exte~~~~~
one extension coupled to a handle;
manipulating said handle such that said extensions separate;
reading a measurement on a scale coupled to said spring; and
selecting an anastomosis connector responsive to said read measurement.
65. A method according to claim 64, comprising further manipulating said
handle to
stretch said graft tip.
66. A hole puncher, comprising:
a sharp tip for forming a puncture in a blood vessel;
a shaft having a varying diameter and having a depression formed therein for
engaging
a wall of said blood vessel, said diameter substantially matching a diameter
of said tip at one
end of the shaft, said diameter increasing away from said tip for a first
distance and said
diameter then defining a slope of diminishing diameter towards said
depression; and
an outer tube mounted on said shaft and having an end, said outer tube having
an inner
diameter of said end that is in a range of diameters defined by said slope of
diminishing
diameters.
67. A puncher according to claim 66, wherein said end of said outer tube has a
smaller
outer diameter that a more proximal portion of said outer tube.
68 A puncher according to claim 66 or claim 67, wherein said diminishing
diameter slope
is obliquely arrange around said shaft.
69. A method of forming an oblique anastomosis connector, comprising:
providing a non-oblique anastomosis connector;
mounting said connector in a restraint:
manipulating said restraints to deform said connector to a desired degree of
obliqueness; and
heat-treating said connector after said manipulation, to maintain said
distortion.
70. A method according to claim 69, comprising heat-treating said connector
prior to said
mounting, to train a deformation of a spike portion of said connector.
28


71. A side mounted delivery system, comprising:
a handle including an opening in its side;
a graft delivery tool adapted to fit through said opening; and
a groove and projection mechanism slidably interconnecting paid tool and said
handle.
72. A system according to claim 71, comprising a snap-lock mechanism for
axially fixing
said handle relative to said tool.
73. A method according to any of claims 59-61, wherein said points are
inverted
simultaneously.
29

Description

Note: Descriptions are shown in the official language in which they were submitted.




CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
LOW PROFILE ANASTOMOSIS CONNECTOR
RELATED APPLICATIONS
This application is a continuation in part of PCT applications PCT/IL99/00284,
PCT/IL99/00285, PCT/IL99/00670 and PCT/IL99/00674, the disclosures of which
are
incorporated herein by reference. This application is also related to a PCT
application filed on
even date in the international bureau as a receiving office and having a title
"ADVANCED
CLOSURE DEVICE" and an attorney docket number 088/01356, the disclosure of
which is
incorporated herein by reference.
FIELD OF THE INVENTION
The present invention relates to anastomosis connectors and especially to
anastomosis
connectors having a low profile.
BACKGROUND OF THE INVENTION
Various types of anastomosis connectors, for connecting two blood vessels,
have been
suggested in the art.
One drawback of some connectors is their non-trivial profile, i.e., the
connectors
project outside of the volume defined by the anastomosis region. As many such
connectors are
formed of hard materials, these extensions may damage nearby tissue. One cause
of these
projections has been the use of spikes that are bent during the anastomosis
procedure. A bent
spike requires a non-trivial bending radius, to prevent spike failure,
especially if the spike is
elastic, super elastic or shape-memory based. It is noted that elastic, super-
elastic and shape
memory bending mechanisms are limited with respect to the amount of elongation
that the
mechanism can faithfully retain. With plastic deformations, the bending is
limited by the
danger of mechanical failure. In general, the range of materials (and their
mechanical
characteristics) available for implantation is quite limited, due to bio-
compatibility
considerations.
US patent 5,234,447 to Kaster, the disclosure of which is incorporated herein
by
reference, describes a plastically deformed anastomosis device for a side to
end anastomosis
between a side vessel and an evened graft. The device comprises a solid ring
having a plurality
of forward spikes and a plurality of backwards spikes extending axially from
the ring. Forward
spikes exit through the tip of the evened graft and typically engage the
target side vessel from
inside. Backward spikes do not need to pierce the graft and engage the target
vessel from its
outside.
1
coNFnr~mo~ co~r



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
SUMMARY OF THE INVENTION
An aspect of some preferred embodiments of the invention relates to providing
a pivot
bar on which a spike of an anastomosis device is mounted. In a preferred
embodiment of the
invention, the pivot bar is not part of the mechanical structure of the
connector, allowing the
spike to deform independently of the deformation of the rest of the connector,
even if the
device deformation is not restricted by a mold. In a preferred embodiment of
the invention, the
pivot bar is used to provide apply sufficient force to the spike, without
requiring a significant
bending radius. Thus, a device whose profile conforms to the blood vessels
being connected,
can be provided. Such a pivot bar can be provided for spikes that engage one
blood vessel or
both blood vessels.
A low profile is useful in a forward spike of the anastomosis connector, for
example to
reduce tension at the connection and/or reduce blood-connector contact. A low
profile is useful
in the backward spike of the connector, for example to minimally impact graft
flexibility
and/or to prevent inadvertent damaging of nearby structures. In some designs,
a low profile
device may also be more easily provided by flexible means, such as a catheter.
Another potential advantage of a low profile device is that the device does
not restrict
the motion of the graft relative to the target vessel. Thus, the graft can
move, and, especially,
the graft can assume a non-perpendicular orientation relative to the vessel.
In other
embodiments, restriction of the graft motion and/or extension direction may be
desired, so an
extended connector may be provided.
In a preferred embodiment of the invention, at least some of the pivot bars
are not
straight, optionally allowing for greater force application at some bending
positions of the
pivot bars.
In one preferred embodiment of the invention, a spike (mounted on a pivot bar)
is cut
out of the material from which an opposing spike is formed.
In a preferred embodiment of the invention, a connector comprises a ring with
a
plurality of radially displaced spikes on pivot bars. Preferably, the pivot
bar heights are
staggered and/or the pivot bars are angled, allowing a better radial
compression of the
connector, during insertion of the connector into the side vessel.
An aspect of some preferred embodiments of the invention relates to an
anastomosis
connector for a side to end anastomosis, in which at least some of the
backward (or forward)
spikes do not penetrate the "side" vessel. Rather, the spikes press against
the vessels and
prevent the "end" vessel from advancing too far (or retracting) into the side
vessel. Preferably,
these pressing spikes are mounted on pivot bars, to allow a large force to be
applied, without
2



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
requiring a significant bend area. Alternatively or additionally, such a
pressing spike can be
substantially parallel to the surface of the "side" vessel, reducing vessel
motion at the
connection area and/or allowing a better spreading out of pressure.
An aspect of some preferred embodiments of the invention relates to the design
of a
ring-part of an anastomosis device. In a preferred embodiment of the
invention, the
anastomosis device comprises a plurality of ring segments arranged in a ring,
with spike
elements between the ring segments. In a preferred embodiment of the
invention, the ring
segments comprises arcs, for example each such ring segment comprising two,
three or four
parallel arcs interconnecting two neighboring spike elements. Preferably, all
the ring segments
have their arcs in the same direction, however, this is not required.
Alternatively to arcs, a ring
segment may comprise one or more zigzag elements, for example including two or
more
bends. In some embodiments, the arc or zigzag thickness may vary along a
single ring
segment.
In a preferred embodiment of the invention, a strengthening or a loop is
provided at the
point of connection between the arc (or other ring segment) and the spike
element. The
strengthening or the loop serves to distribute strain caused by radially
contracting the
connector and/or to prevent over-straining at the point of connection.
An aspect of some preferred embodiment of the invention relates to a graft
eversion
mechanism. In a preferred embodiment of the invention, the eversion mechanism
comprises a
graft holder and a plurality of forceps like devices. In a preferred
embodiment of the invention,
the forceps like devices can be operated in tandem, to grasp the ends of the
graft, even it and
then pull the evened part back over the rest of the graft. Preferably, the
different forceps pull
the graft back different amounts, forming an uneven eversion.
An aspect of some preferred embodiments of the invention relates to performing
an
oblique eversion. In a preferred embodiment of the invention, it is noted that
an obliquely
evened graft, especially a vein, tends to form an oblique anastomosis
connection and the graft
tends to bend back to relieve the strain caused by the oblique eversion.
Preferably, the degree
of obliqueness is selected responsive to an expected bending of the graft
after the anastomosis
is completed.
An aspect of some preferred embodiments of the invention relates to a method
of
forming an oblique-connection anastomosis device. In a preferred embodiment of
the
invention, a perpendicular-connection anastomosis device is formed and then
bent out of
shape, to provide an oblique device. The bent device is preferably heat
treated to train it to its
new geometry.
3



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
An aspect of some preferred embodiments of the invention relates to an
apparatus for
delivering a graft to an anastornosis location. In a preferred embodiment of
the invention, the
apparatus comprises two parts, a handle, and a replaceable inner-tool, which
can be, for
example, a hole-puncher or a graft delivery and anastomosis performance tool.
In a preferred
embodiment of the invention, the inner tool is inserted into the handle from
the side of the
handle. In an exemplary embodiment, the tool is inserted into the side of the
handle and than
slid axially a short distance to lock. A potential advantage of this method is
that a vein can be
mounted on the graft delivery tool prior to its being mounted o the handle and
there is little
danger of the vein being damage by the handle.
An aspect of some preferred embodiments of the invention relates to a punch
for
punching holes in blood vessels. Such a punch may be used from outside the
body, or form
inside the body, for example being provided through an endoscope or a
catheter. In a preferred
embodiment of the invention, the punch comprises a pointed shaft having a
circumferential
depression with defined therein. At least the end of the depression near the
tip is sloping. An
outer tube is provided over the shaft. The tip of the tube has a smaller inner
diameter than the
rest of the tube. In operation, the tip is inserted into a side of a blood
vessel until the vessel
wall is engaged by the depression. The tube is then advanced. The vessel wall
is cut between
the inner diameter of the outer tube and the sloping edge of the depression.
The cut out portion
is preferably contained in the depression.
An aspect of some preferred embodiments of the invention relates to a device
for
measuring and preferably pre-stretching a graft before an anastomosis
procedure. In a
preferred embodiment of the invention, the device comprises two bars, a first
one connected to
a handle and a second one connected to a weak spring and a scale. The graft is
mounted on the
two bars. When the handle is pulled, the motion of the first bar is coupled to
the second bar via
the graft. The motion of the second bar is limited by the spring. The scale
shows the relative
distance between the two bars, allowing a suitable anastomosis connector to be
selected.
Further pulling on the handle can be used to pre-stretch the vein in
preparation for eversion
and/or mounting of the anastomosis connector on it.
There is thus provided in accordance with a preferred embodiment of the
invention, an
anastomosis connector, comprising:
a plurality of ring segments, together defining a radially expandable ring-
like shape
having a lumen;
at least one pivot bar coupled to at least one of said ring segments; and
at least one spike mounted on said pivot bar and rotatable around said pivot
bar,
4



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
where radial deformation of said ring-like shape does not substantially
directly affect
said spike rotational position. Preferably, rotation of the pivot bar is
mechanically decoupled
from radial deformation of ring-like shape. Preferably, said at least one
pivot bar comprises at
leas two pivot bars, where said at least one spike is mounted on a first one
of said pivot bars
and said first pivot bar is mounted on the other pivot bar.
In a preferred embodiment of the invention, said at least one spike is pointed
towards
said ring-like shape. Alternatively, said at least one spike is pointed away
from said ring-like
shape.
In a preferred embodiment of the invention, said at least one spike comprises
at least
two spikes, each mounted on a separate pivot bar, where said spikes point in
opposite
directions along an axis of said connector.
In a preferred embodiment of the invention, said connector is designed such
that said at
least one spike remains outside of a side vessel in an end-to-side
anastomosis. Alternatively or
additionally, said connector is designed such that said at least one spike
enters a side vessel in
an end-to-side anastomosis.
In a preferred embodiment of the invention, said pivot bar is comprised in a
spike
element. Preferably, said spike element comprises two opposing spikes.
Alternatively or
additionally, said spike element interconnects two adjacent ring segments.
Alternatively, said
spike element is attached to only a single ring element.
In a preferred embodiment of the invention, said at least one spike has a tip
adapted to
penetrate a blood vessel. Alternatively, said at least one spike has a tip
adapted to lay against a
blood vessel without penetrating it.
In a preferred embodiment of the invention, said connector is heat-treated to
have said
at least one spike perpendicular to said ring. Alternatively, said connector
is heat-treated to
have said at least one spike parallel to said ring.
In a preferred embodiment of the invention, said connector is heat-treated to
have said
at least one spike bend. Alternatively, said connector is heat-treated such
that said at least one
spike does not bend.
In a preferred embodiment of the invention, said connector is heat-treated
such that
said pivot bar is twisted. Alternatively, said connector is heat-treated such
that said pivot bar is
not twisted.
In a preferred embodiment of the invention, said pivot bar is within an axial
extent of
said ring-like shape. Preferably, said pivot bar is substantially centered
relative to said ring like
shape.
5



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
Alternatively, said pivot bar is outside an axial extent of said ring-like
shape.
In a preferred embodiment of the invention, said pivot bar is comprised in a
pivot
mechanism. Preferably, said pivot mechanism is directly mounted onto at least
one of said ring
elements Alternatively, said pivot mechanism is coupled via a single extension
to at least one
of said ring elements. Alternatively, said pivot mechanism is coupled via at
least two
extensions to at least one of said ring elements.
In a preferred embodiment of the invention, said pivot bar is coupled to said
pivot
mechanism via a hinge at each end of said pivot bar. Preferably, said hinge
comprises a
thickening of said mechanism relative to said pivot bar.
In a preferred embodiment of the invention, said connector comprises a
plurality of
alternating ring segments and pivot bar mechanism and said pivot bar
mechanisms are axially
staggered, to allow a greater radial compression of said ring-like shape.
In a preferred embodiment of the invention, said pivot bar is straight.
Alternatively,
said pivot bar is piece-wise straight. alternatively, said pivot bar is
curved.
In a preferred embodiment of the invention, said connector is packaged.
Preferably,
said packaging indicates a particular vessel type for said connector and for
which said
connector is adapted. Preferably, said vessel type comprises a femoral artery.
Alternatively,
said vessel type comprises an aorta.
In a preferred embodiment of the invention, said packaging indicates a
particular vessel
size for said connector and for which said connector is adapted. Alternatively
or additionally,
said packaging indicates a particular vessel wall thickness for said connector
and for which
said connector is adapted. Preferably, said ring-like shape has an axial
extent smaller than said
wall thickness.
In a preferred embodiment of the invention, said packaging indicates a
particular
connection geometry for said connector and for which said connector is
adapted. Preferably,
said geometry is a side-to-end geometry.
In a preferred embodiment of the invention, said packaging indicates a
particular
oblique angle geometry for said connector and for which said connector is
adapted.
In a preferred embodiment of the invention, said at least one spike is cut out
of an
opposing spike of said connector.
In a preferred embodiment of the invention, at least one of said ring segments
comprises a plurality of axially spaced elements. Preferably, said plurality
of elements
comprises at least three elements. Alternatively, said plurality of elements
comprises at least
four elements. Alternatively, said plurality of elements comprises at least
five elements.
6



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
In a preferred embodiment of the invention, all of said plurality of elements
have a
same geometry. Alternatively, at least two of said plurality of elements have
mirrored
geometries.
In a preferred embodiment of the invention, at least one of said plurality of
elements
has a single curve geometry. Alternatively, at least one of said plurality of
elements has a dual
curve geometry. Alternatively, at least one of said plurality of elements has
at least three
curves defined thereby.
In a preferred embodiment of the invention, at least one of said plurality of
elements
has a varying width. Alternatively, all of said plurality of elements have a
constant width.
In a preferred embodiment of the invention, the connector comprises a strain
dissipation element at a point of connection of at least one of said elements
and a spike
element to which said ring segment is attached. Preferably, said strain
dissipation element
comprises a thickening of said axially spaced element. Preferably, said
thickening defines an
aperture.
There is also provided in accordance with a preferred embodiment of the
invention, a
method of everting a blood vessel, comprising:
engaging a tip of said vessel at a plurality of points around its
circumference;
inverting said tip by inverting said points; and
pulling said inverted points towards a distal end of said blood vessel.
Preferably, said
plurality comprises four points. Alternatively or additionally, said engaging
comprises
engaging using forceps and where said inverting comprises rotating said
forceps. Alternatively
or additionally, said pulling comprises pulling different ones of said points
different amounts.
There is also provided in accordance with a preferred embodiment of the
invention,
apparatus for graft eversion of a graft over a shaft having a tip, comprising:
a handle for engaging said shaft;
a plurality of forceps arranged to engage a tip of said graft where it
protrudes form said
shaft; and
a plurality of joints, each one associated with one of said forceps, for
rotating said
forceps pulling a tip of each of said forceps axially along said shaft.
There is also provided in accordance with a preferred embodiment of the
invention, a
method of measuring a graft size, comprising:
mounting a tip of said graft on two extensions, one extension coupled to a
spring and
one extension coupled to a handle;
manipulating said handle such that said extensions separate;
7



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
reading a measurement on a scale coupled to said spring; and
selecting an anastomosis connector responsive to said read measurement.
Preferably,
the method comprises further manipulating said handle to stretch said graft
tip.
There is also provided in accordance with a preferred embodiment of the
invention, a
hole puncher, comprising:
a sharp tip for forming a puncture in a blood vessel;
a shaft having a varying diameter and having a depression formed therein for
engaging
a wall of said blood vessel, said diameter substantially matching a diameter
of said tip at one
end of the shaft, said diameter increasing away from said tip for a first
distance and said
diameter then defining a slope of diminishing diameter towards said
depression; and
an outer tube mounted on said shaft and having a tip, said outer tube having
an inner
diameter of said tip that is in a range of diameters defined by said slope of
diminishing
diameters. Preferably, said tip of said outer tube has a smaller outer
diameter that a more
proximal portion of said outer tube.
There is also provided in accordance with a preferred embodiment of the
invention, a
method of forming an oblique anastomosis connector, comprising:
providing a non-oblique anastomosis connector;
mounting said connector in a restraint;
manipulating said restraints to deform said connector to a desired degree of
obliqueness; and
heat-treating said connector after said manipulation, to maintain said
distortion.
Preferably, the method comprises heat-treating said connector prior to said
mounting, to train a
deformation of a spike portion of said connector.
There is also provided in accordance with a preferred embodiment of the
invention, a
side mounted delivery system, comprising:
a handle including an opening in its side;
a graft delivery tool adapted to fit through said opening; and
a groove and projection mechanism slidably interconnecting said tool and said
handle.
Preferably, the system comprises a snap-lock mechanism for axially fixing said
handle relative
to said tool.
BRIEF DESCRIPTION OF THE DRAWINGS
Particular embodiments of the invention will be described with reference to
the
following description of preferred embodiments, in conjunction with the
figures. The figures
are generally not shown to scale and any measurements are only meant to be
exemplary and
8



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WO 00/56228 PCT/IB00/00310
not necessarily limiting. In the figures, identical structures, elements or
parts which appear in
more than one figure are preferably labeled with a same or similar number in
all the figures in
which they appear, in which:
Fig. 1 is plan view of a part of a pivot-bar based anastomotic connector, in
accordance
with a preferred embodiment of the invention;
Figs. 2A-2E illustrate a deployment method for the connector of Fig. 1, in
accordance
with a preferred embodiment of the invention;
Fig. 3 is plan view of a part of another pivot-bar based anastomotic
connector, in
accordance with an alternative preferred embodiment of the invention;
Figs. 4A-4C illustrate a deployment method for the connector of Fig. 3, in
accordance
with a preferred embodiment of the invention;
Fig. 4D is a cut-sectional view of an heat-treating device suitable for pivot-
bar based
anastomosis connectors, in accordance with a preferred embodiment of the
invention;
Fig. 5 is plan view of a part of a pivot-bar based anastomotic connector,
featuring
spikes cut out of spikes in accordance with a preferred embodiment of the
invention;
Figs. 6A-6C illustrate various spike designs utilizing a pivot-bar or a
similar hinge, in
accordance with preferred embodiments of the invention;
Figs. 6D-6E illustrate a spike design utilizing two pivot bars, in accordance
with a
preferred embodiment of the invention;
Figs. 7A-7B illustrate an oblique anastomosis connector utilizing a pivot bar
design, in
accordance with a preferred embodiment of the invention;
Figs. 8A-8E illustrate various anastomosis connector designs, in accordance
with
preferred embodiments of the invention;
Figs 9A and 9B illustrate a connector-bending device, in accordance with a
preferred
embodiment of the invention;
Fig. 10 illustrates an alternative connector-bending device, in accordance
with a
preferred embodiment of the invention;
Fig. 11 is a cross-sectional view of a graft measurement and/or stretching
device in
accordance with a preferred embodiment of the invention;
Figs. 12A-12C illustrates a side-mounted anastomosis delivery system, in
accordance
with a preferred embodiment of the invention;
Figs. 13A-13F illustrate a graft eversion tool, in accordance with a preferred
embodiment of the invention; and
9



CA 02366708 2001-09-13
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Fig. 14 illustrates a tip of a hole-punching tool, in accordance with a
preferred
embodiment of the invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Fig. 1 is plan view of a part of a pivot-bar based anastomotic connector 100,
in
accordance with a preferred embodiment of the invention. Connector 100 is
generally ring
shaped. formed of a plurality of ring segments 102 and a plurality of spike
elements 104
interspersed between the ring segments. It is noted however, that other
connector designs, can
be used, for example, the spike elements being independent of the ring
segments.
A ring segment forms part of the ring structure of the connector and is
typically, but
not always, radially compressed, to allow easier insertion into a blood
vessel. In a preferred
embodiment of the invention, each ring segment 106 comprises a~ plurality of
side-by-side
elements 106, which are preferably elastic.
A spike element supports one or more opposing spikes, for example spikes 118
and
108 as shown. Spike 108 is shown with a sharp tip 109, for penetrating a graft
vessel, as will
be explained below with respect to Fig. 2.
A particular feature of connector 100 is that one or both of spikes 108 and
118 are
mounted on a pivot bar 110 or 120, such that the spike can be extended into
the figure plane
without substantially bending the spike, only by twisting the pivot bar.
Furthermore, the
amount of distortion of the pivot bar is considerably smaller than that of a
comparable in-line
hinge, such as is formed by a bending of the spike. Thus, the deformation is
less likely to cause
hinge failure and/or a hinge can be configured to also apply greater force to
the spike.
Although the spikes are shown mounted at the center of their pivot bars, this
is not essential.
In connector 100, the pivot bars 110 and 120 are shown are being axially
spaced from
the connector by extensions 114 and 116, respectively. However, as will be
shown in
alternative embodiments below, this is not required.
A joint 112 attaches pivot bar 110 to extension 114. In this joint, the spacer
is made
thicker than the pivot bar, to prevent undesirable twisting of the spacer or
any part of the
connector other than pivot bar 110. Other variations of joints will be
described below. It is
noted, that strengthened or weakened portions may be provided at other points
along the pivot
bars, besides at their ends, to control where deformation takes place.
In a preferred embodiment of the invention, the pivot bar is not a load
bearing structure
or a radially expanding structure, so that the forces applied to the spike can
be independent of
the radial expansion forces. Another potential advantage of this separation is
that the radial



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
expansion of connector 100 as a whole does not have to affect the spike
positions vis-a-vis
extensions and/or the rest of the connector.
Another potential advantage of pivot bars, is that the profile (e.g.,
protrusions from the
anastomosis location) of the connector can be reduced.
Another potential advantage, realized in spike 118, is that the spike does not
need to
penetrate the blood vessel at all. Rather, the force applied by the pivot bar
is sufficient to hold
the spike against the blood vessel (as shown below in Fig. 2), without
penetrating it.
Figs. 2A-2E illustrate an exemplary deployment method for connector 100, in
accordance with a preferred embodiment of the invention. Connector 100 is
preferably heat
trained to have a resting configuration as shown in Fig. 2E, with spikes 108
and 118 extending
perpendicular to the connector surface.
Fig. 2A shows a connector 100 with both spikes axially aligned, mounted
between a
holder 134 and a graft cover 136. A graft 132 is provided everted over graft
cover 136 and
connector 100, and inside an aperture in the wall of a "side" vessel 130. A
base tube 138
maintains connector 100 in its axial position relative to the rest of the
delivery system.
As shown in Fig. 2A, tips 109 of spikes 108 transfix graft 132, at its
eversion. In Fig.
2B, the base tube 138 is advanced relative to holder 134 and cover 136, so
that spike 108
advances into the aperture in vessel 130 and reverts to its resting
configuration perpendicular
to connector 100. Since most, if not all of the bending is in pivot bar 118,
the side profile of
the extended spike can be substantially perpendicular. Tips 109 may be trained
to be slightly
bent towards the near vessel wall, to prevent them from protruding into vessel
130.
In Fig. 2C, holder 134 is retracted, allowing connector 100 to expand
radially, at its
ring segments 102.
In Fig. 2D, holder 134 is retracted even more, releasing spikes 118 to bend
perpendicular to connector 100. As a result, vessel 130 is grasped between
spikes 108 and
spikes 118. It is noted that spikes 118 do not penetrate and blood vessel,
while spikes 108 only
penetrate graft 132, not vessel 130. Alternatively, spikes 108 may extend
directly into the side
of vessel 130.
In Fig. 2E, graft cover 136 is retracted and the anastomosis is completed.
In a preferred embodiment of the invention, the spikes and spike tips are
designed to
support vessel 130. In one exemplary embodiment, the spikes are wide.
Alternatively, the
spikes are roughed on their inner surface where they contact vessel 130.
Alternatively, the
spike tip may be wider than the spike, for example to define a contact pad
between the spike
and vessel 130.
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Connector 100 is preferably formed of a elastic, super-elastic or shape-memory
material, such as Nitinol. However, connector 100 may alternatively be
plastically deformed.
In one example, holder 134 engages spikes 108, when it is retracted, it bends
spikes 108, by
twisting pivot bar 110. Once spikes 108 are bent sufficiently, holder 134 may
disengage the
spikes. A suitable holder tip for engaging and disengaging is shown, for a
different purpose, in
Fig. 9B. When the tip is rotated, the engaged spike is released.
Fig. 3 is plan view of a part of a pivot-bar based anastomotic connector 200,
in
accordance with an alternative preferred embodiment of the invention.
Similar to connector 100, connector 200 comprises a plurality of ring segments
202,
comprising two arcs 206 and a plurality of spike elements 204, each comprising
a spike 208
and a spike 218. It is noted that a particular spike element 208 does not need
to include two
opposing spikes and may include one or more than one spike in each axial
direction.
This connector, as are other embodiments described herein, is selected to
exemplify a
plurality of design features. A connector in accordance with a preferred
embodiment of the
invention is not to be construed as being limited to the particular mix of
features illustrated.
Rather, the embodiments were chosen to illustrate several features in each
embodiment, with
the understanding that other embodiments within the scope of the invention can
contain any
selection of features from any of the embodiments shown.
One feature of connector 200 is that a pivot bar 220 of spike 218 is within
the axial
extent of ring segment 202. Thus connector 200, when deployed; can have a
smaller axial
extent than connector 100. In the embodiment shown, spike 208, which may be a
forward
spike, does not have a pivot bar and the spike itself is bent for deployment.
Another feature exemplified by connector 200, is that the pivot bars for two
adjacent
spike segments 204 and 204' are not at the same axial position. Thus, the
pivot bars of adjacent
spike elements do not contact during radial compression of connector 200.
Another feature of connector 200, is that a pivot bar 220 of spike 218 is not
straight. As
shown, the pivot bar is V shaped, however, a sine shape or a zigzag shape
could also be
provided. Spike 218 is preferably, but not necessarily, attached at the bend
in pivot bar 220. A
potential advantage of the V shaped designed showed is that a greater force
can be applied
over part of the bending positions of spike 218, than can be with a similar
straight pivot bar.
Alternatively, the pivot bar may be tilted to provide space for axial
compression, but remain
straight.
Another feature of connector 200 is that the mechanism supporting the pivot
bars forms
substantially square corners that jut into the neighboring ring segments.
Alternatively, these
12



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
corners may be rounded. Optionally, the pivot bar is bent to conform with the
connector
surface, however, this is not essential, especially in those connectors where
the pivot bar is
coupled to the connector at only a single point.
Another feature of connector 200, which will be illustrated in Fig. 4 that
describes the
deployment, is that the spikes are both bent and twist around the pivot bars.
Thus, spikes 218
include a forked tip 219, for spearing vessel 130. However, this spearing can
be at an angle
significantly shallower than 90°, for example 60° or 30°.
Figs. 4A-4C illustrate a deployment method for connector 200, in accordance
with a
preferred embodiment of the invention.
Fig. 4A shows connector 200 after its forward spike 208 is released to engage
vessel
130. A method similar to that shown in Fig. 2 may be used for releasing the
spikes (which may
be super-elastic), or other methods, for example as described in the above
referenced PCT
applications, can be used.
Spikes 218 are preferably held between a connector holder 238 and a outer tube
234,
during and shortly following the engagement of vessel 130 by spikes 208. A
connection
positioner 240 may be provided to control the position of connector 200
relative to vessel 130
and provide a counter-force for retracting connector 200 so that spikes 209
engage vessel 130.
In Fig. 4B, outer tube 234 is retracted, freeing spike 218 to bend. As shown,
both spike
218 and pivot bar 220 bend, with the result that spike tip 219 engages vessel
130.
In Fig. 4C, an optional step of advancing outer tube 234 is illustrated, this
advancing
further bends spike 218 and strengthens the engagement of vessel 130.
Fig. 4D is a cut-sectional view of an heat-treating device 250 suitable for
pivot-bar
based anastomosis connectors, in accordance with a preferred embodiment of the
invention.
connector 200 (or 100) is placed in device 250. This placement requires
distorting the
connector as shown. Device 250 is then heated to heat-treat the connector and
make the new
configuration its resting configuration to which the connector tends to return
after distortion.
Two types of spikes 218 are shown in Fig. 4D, namely, a penetrating spike 218
is as
shown in Fig. 3, and a contact spike 218' does not penetrate vessel 130.
Optionally, the contact
spikes are distanced from the connector center, to allow more force to be
applied to vessel 130
during deployment.
A single connect may include both penetrating and contact spikes 218, as
shown, or the
connect may comprise only contact spikes 218' or only penetrating spikes 218.
Fig. 5 is plan view of a part of a pivot-bar based anastomotic connector 300,
featuring
spikes cut out of larger spikes in accordance with a preferred embodiment of
the invention. As
13



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
with the above connectors, connector 300 comprises a plurality of ring
segments 302 each
formed of a pair of arcs 306. A spike 308 is cut out of the body of a spike
318. A pivot bar 310
of spike 308 is mounted on optional extension tabs 314.
One feature of connector 300 is that the spikes bases are defined within the
axial extent
of ring segments 302.
Another featured of connector 300 is that spikes 318 are hollow, so that a
smaller
amount of foreign material is present and better tissue adhesion, across the
spike, can be
provided.
Another feature of connector 300 is that pivot bar 310 is mounted on extension
tabs
314. Thus, the axial location of pivot bar 310 can be set after the connector
manufacture, by
bending tabs 314 a desired amount and then heat treating the device to
finalize the tab location.
In the above embodiments, graft 132 is typically transfixed by spikes 108, 208
or 308.
Alternatively, no such transfixing is provided. In this alternative
embodiment, ring segments
306 are provided inside of the evened part of graft 132. Tabs 314 are folded
back past the edge
of the eversion and then optionally again forward, so that spikes 308 and
pivot bar 310 are on
the outside of the evened section of graft 132. Optionally, spikes 308 are
defined in the center
of ring segments 306, rather than between the segments, and the evened portion
of graft 132 is
held between ring segments 306 and pivot bar 310.
Figs. 6A-6C illustrate various spike designs utilizing a pivot-bar or a
similar hinge, in
accordance with preferred embodiments of the invention. As will be shown in
the embodiment
of Fig. 6D, these spikes may be extended differently from the spikes described
above. In
particular, these spikes may be pointed towards the ring of the connector, at
least during
manufacture.
In Fig. 6A, a spike mechanism 330 includes a pair of spikes 332 mounted on a
base
336, which base includes an extension 334. Base 336 can serve as a pivot bar,
inasmuch as the
rotation of spikes 332 is supported by distortion of a significant length of
base 336. Extension
334 may server for holding spike 332 during insertion.
In Fig. 6B, spike mechanism 340 features a spike 342, mounted on an extension
portion 344 of a base 346, possibly allowing better control of the bending and
a reduction in
the volume taken up the rotation of the spike.
In Fig. 6C, a spike mechanism 350 features a spike 352 mounted directly on a
base
356. It is noted that various spike lengths may be provided, within the scope
of the invention,
the spike lengths preferably being selected to penetrate vessel 130 only a
desired amount.
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WO 00/56228 PCT/IB00/00310
Figs. 6D-6E illustrate a spike mechanism 360 utilizing two pivot bars, in
accordance
with a preferred embodiment of the invention. Fig. 6D is a plan view.
Mechanism 360 has two
spikes 362 mounted on a pivot bar 364. Pivot bar 364 is itself mounted, via
two extensions 368
on a second pivot bar 366. A portion 370 connects mechanism 360 with the rest
of a connector
372.
Fig. 6E is a side view of a deployed connector 372. Mechanism 360 is bent
twice, once
at pivot bar 366 and once at pivot bar 364. This allows a substantially square
profile to be
produced, which conforms to the blood vessels taking part in the anastomosis.
Also shown is
an opposing spike 374, which may be of any type.
It should be noted that a single pivot bar can be used to provide a wide range
of
rotation angles, such as between 15° and 180°, or even over
180°. In some embodiments, a
double pivot bar is provided for large angles of rotations, however, this is
not required.
Figs. 7A-7B illustrate an oblique anastomosis connector 400 utilizing a pivot
bar
design, in accordance with a preferred embodiment of the invention. Fig. 7A is
a plan view of
a part of connector 400. Connector 400 comprises a plurality of ring segments
402, each
comprises a plurality of arc sections 406. A forward bending spike 408 is
provided, with a tip
409. A pair of backward spikes 418 are mounted on a pivot bar 420. Bar 420 is
separated from
connector 400 by a pair of extensions 414, however, a single extension or
three or more
extensions could be used.
Device 400 is built to be oblique, thus, the ring segments do not lie on a
straight line,
but on a wavy line, preferably corresponding to the final shape of the
connection. In the
embodiment shown, the spikes are parallel to the connector axis.
Alternatively, the spikes
and/or the pivot bars may be tilted or even parallel with the axis defined by
the lumen of
connector 400 (this axis is perpendicular to the ring plane of the connector).
Fig. 7B is a side cross-sectional view of a deployed connector 400.
It should be noted that spikes 418 and spikes 408 can be designed to push in
opposite
radial directions, for example spikes 408 pushing in and spikes 418 pushing
away from the
anastomosis connection. Thus, the wall of vessel 130 can be radially engaged
by the spikes.
Alternatively, the spikes apply a stretching force to the wall of vessel 130.
In either case, the
spike position and force application direction can be used to isolate the rest
of vessel 130 from
the forces applied by the anastomosis connection, optionally, while
compressing a part of the
wall of vessel 130 between at least some of the spikes (not necessarily all
from the same axial
set) and the ring-part of the spike.



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
Figs. 8A-8E illustrate various anastomosis connector designs, in accordance
with
preferred embodiments of the invention.
Fig. 8A is a plan view of a portion of an anastomosis connector 500, in which
each ring
segment 502 is formed of a plurality of zigzag elements 506. Elements 506 may
have a
constant width or their width may vary. One expected benefit of using zigzag
elements is that
the connector is less likely than an arc-based device to distort in an
unexpected manner.
Another potential benefit of zigzag ring segments is that the force applied by
the expanding
ring can be better matched to the needs of the anastomosis.
Fig. 8B is a plan view of a portion of an anastomosis connector 520, in which
each ring
segment 522 is formed of a plurality of arc elements 526. In connector 520,
five arc elements
526 are provided. In other embodiments, a different number of arc-elements may
be used, for
example three or four.
The term arc-element is used for convenience, the actual curve of each element
506
need not be that of an arc of a circle, for example being a spline or a
segment of an ellipse.
Alternatively or additionally, the different elements may have different
shapes and/or widths,
for example the radius of curvature increasing in an axial direction.
In a typical manufacturing process, two connectors overlap in the raw
material, for
example the spikes of one connector interleaved with the spikes of a next
connector. Thus, the
manufacturing process can be more efficient with respect to waste material.
Fig. 8C is a plan view of a portion of an anastomosis connector 530, in which
each ring
segment 532 is formed of a plurality of arc elements 536. In connector 530,
four arc elements
are provided, arranged in the form of two concentric near ellipses. At the
point of contact
between an arc-element 536 and a spike element 534, a strengthening or a loop
538 is
preferably provided, to prevent stress related damage from occurring at that
point.
Fig. 8D is a plan view of a portion of an anastomosis connector 540, in which
each ring
segment 542 is formed of a plurality of recurved elements 546. In connector
540, two such
recurved elements are provided. As shown, a plurality of forward spikes 548
have different
lengths. These different lengths may be used for forming an oblique
anastomosis connector
and/or for oblique anastomosis connections, as described below, for example.
The number of
curves in the recurved element can be greater, for example, being three, four
or more.
Fig. 8E shows a connector 550 similar to connector 500 of fig. 8A, in which
four,
rather than three zigzag elements 556 are provided.
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It should be appreciated that the number, shape, thickness and mechanical
working of
the ring segments are determined based on a desired mechanical behavior.
Typically, but not
necessarily, the desired parameters are:
(a) withstanding stress fracture;
(b) sufficient radial force against vessel 130;
(c) provision of a seal against leakage;
(d) matching of vessel 130 wall thickness; and/or
(e) pulsile and other characteristics of the vessel for which they are
designated.
In addition, to the above variations, the ring segment design may vary between
elements in a single connector, for example being alternately arc elements and
zigzag
elements.
In a preferred embodiment of the invention, structural elements are added to
the
connector to prevent to large an increase in radius, for example by providing
struts or wires
that interconnect neighboring spike elements and prevent them from separating
too much.
Oblique connectors may be formed by obliquely cutting metal tubes or sheet
metal.
Alternatively, an oblique connector is formed by manufacturing a perpendicular
connector and
then distorting it to make it oblique. In an exemplary embodiment, the above
connectors may
be formed by cutting a suitable Nitinol tube, for example having an outer
diameter of 5.3 mm
and having a material thickness of 0.18 mm.
Figs 9A and 9B illustrate a connector-bending device 600, in accordance with a
preferred embodiment of the invention. Fig. 9A is a side cross-sectional view
of device 600. A
connector 602, preferably after it is heat-treated to learn a new resting
configuration of its
spikes, is mounted on two tools 604, each of which engages the spikes of one
side of connector
602. A screw 608 is used to fix one tool 604 to a bottom base 610 and another
screw 608 is
used to fix the other tool 604 to a top base 612. The two bases are moved
relative to each
other, such that connector 602 is distorted. The two bases are then attached
to each other using
screws 614 and the entire device is placed in an oven for additional heat-
treating.
Fig. 9B is a top view of tool 604, showing L shaped slots for engaging the
spikes of
connector 602 and an inner-threaded aperture for engaging screw 608.
Fig. 10 illustrates an alternative connector bending device 630, in which a
same base
612, screw 608 and tool 604 are used to engage one end of connector 602.
However, the
connector is distorted by inserting a stylet 632 into the lumen of connector
602. The cross-
section of stylet 632 can be any desired cross-section. A second based 634
fixes the stylet in
place and, the device and connector are placed in an oven for heat-treating.
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WO 00/56228 PCT/IB00/00310
Fig. 11 is a cross-sectional view of a graft measurement device 700, in
accordance with
a preferred embodiment of the invention. Device 700 comprises a body 701
having a handle
702 at one end thereof. A graft 132 is placed on two projections 704 and 710.
Projection 704 is
coupled to a piston 706 that is fixed to handle 702. Projection 710 is coupled
to a piston 708,
which is coupled to body 701 via a weak spring 714. A scale 712 is mounted on
piston 708.
In operation, an extension force applied to handle 702 is coupled to piston
708 via graft
132. The diameter of graft 132 affects the measurement shown on scale 712. An
additional
extension of handle 702, possibly until a block, stretches graft 132 in
preparation for eversion.
It will be appreciated by a person skilled in the art that other ways of
coupling the diameter of
the graft to the extension of a weak spring can also be used to the same
effect. It is noted that
over-stretching of graft 132 can be prevented by selecting a spring that
yields before the graft
does or by selecting a spring that even when stretched to its maximum allowed
length does not
apply a force above a safety threshold.
Figs. 12A-12C illustrates a side-mounted anastomosis delivery system, in
accordance
with a preferred embodiment of the invention. In a preferred embodiment of the
invention, a
single handle 800 is used to provide various tools to the anastomosis
location. Two exemplary
tools are a graft delivery tool 802 and a hole puncher (not shown).
In a preferred embodiment of the invention, the tools are loaded into handle
800 from
the side of handle 800. A slide and snap mechanism is shown as an exemplary
method of
achieving side loading. Tool 802 has at least one rail 808 defined on it and
handle 800 has a
matching groove 810. A projection 814 on tool 802 matches a projection 812 in
handle 800.
The grooves and the projection may be switched between the handle and the
tool.
Fig. 12A shows handle 800 separated from tool 802. In Fig. 12B, groove 810
engages
rail 808. In Fig. 12C, tool 802 is advanced enough so that projections 814 and
812 interlock.
Tool 802 may be removed by applying sufficient retraction force, to overcome
the
resistance of the projections, either bending them away or breaking them (for
a one-time
device).
In operation, a graft 132, such as a vein, is inserted into an opening 804 in
tool 802 and
exits at its open tip 806. Tip 806 with the graft on it is then inserted into
an aperture in vessel
130 (e.g., Fig. 2). One potential advantage of side loading the graft holding
tool 802 into
handle 800, is that the vein is less likely to be damaged by passage through
handle 800, if such
passage is minimized.
Another potential advantage is that it is easier to mount and navigate a short
vein on a
side-mounted tool. It is noted that graft mounting may be required to be
performed even if the
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WO 00/56228 PCT/IB00/00310
vein is still connected to the body, in which case, possibly, the vein cannot
be removed from
the body at all, or any significant distance.
Tool 802 can correspond, for example to the device used in Fig. 2, with tip
806
corresponding to graft holder 136.
Figs. 13A-13F illustrate a graft eversion tool 900, in accordance with a
preferred
embodiment of the invention.
Tool 900 comprises a hollow shaft 902 for engaging a graft delivery tool, such
as tool
802 (Fig. 8) and a plurality or forceps mounting points 904 (four shown in
this exemplary
embodiment, but other embodiments may have as few as one, two or three or
more, such as
five or six). Preferably, a forceps 906 is mounted on each mounting point 904,
using a forceps
mechanism 908. However, for clarity, the figures show only a single forceps in
one forceps
mounting mechanism. Also, graft 132 is not shown.
Fig. 13A shows device 900 prior to the provision of tool 802.
In Fig. 13B, tool 802 is provided in shaft 902. A graft is provided through
opening 804
in tool 802 and out of its tip 806. In this figure, a perpendicular, rather
than an oblique tip 806
is shown. However, an oblique tip, for example as in Fig. 12, may be used
instead, and the
motion of forceps 906 is preferably matched to the obliqueness. Depending on
the
embodiment, an anastomosis connector (not shown) may already be mounted on tip
806, such
that the vein evened over it.
In Fig. 13C, forceps 906 is brought over the tip of graft 132 and closed. It
is noted that
four pairs of forceps are thus closed on different pans of the graft tip.
In Fig. 13D, all four forceps are rotated using their mechanism 908, so that
the graft is
evened. Preferably, all the forceps are rotated simultaneously, alternatively,
they are rotated in
series. Many mechanism can be used to effect the simultaneous rotation.
In Fig. 13E, the forceps are pulled down, elongating the eversion length.
Optionally,
each forceps pulls down a different amount, thereby forming an oblique
eversion. Optionally
tip 806 has an oblique end, to support the oblique eversion. It is noted that
many types of joint
mechanisms can be used to effect the rotation and pulling down of the forceps
tips.
In Fig. 13F, the forceps are opened, releasing the graft and allowing tool 802
to be
removed and inserted into handle 800 (if it is not already so inserted.
The .inventors have discovered that when a vein is evened obliquely, that is
with the
evened pan having different lengths along the circumference of the eversion,
the evened vein
tends to bend after a while, in an attempt to release the strain caused by the
uneven eversion. In
a preferred embodiment of the invention, this mechanism is utilized when
forming an eversion,
19



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
even using a non-oblique anastomosis device, with the result that the graft
curves after the
anastomosis is completed.
Fig. 14 illustrates a tip of a hole-punching tool 950, in accordance with a
preferred
embodiment of the invention. The side of the figure to the left of the axis
shows the tip prior to
hole punching and the side of the figure to the right of the axis shows the
tip after the punching
is completed.
Punch 950 comprises an anvil 954 and an outer cutting tube 952. Preferably, a
sharp
inner tip 956 is used to form an initial hole in vessel 130 and then tip 956
is retracted. After
forming the hole anvil 954 is advanced until vessel 130 is engaged by a
depression 958 in
anvil 954. Depression 958 preferably has an inclined side 962. Cutting tube
952 has a forward
portion having a reduced inner diameter that is smaller than the outer
diameter of the sides of
depression 958. Thus, when cutting tube 952 is advanced, vessel 130 is cut
between inclined
side 962 and the tip of cutting tube 960. A benefit of this design is the
relative laxity of
tolerances, as long as the inner diameter of cutting tube 960 matches a
diameter of some point
of slope 962.
Punch mechanism 950 can be used for both straight and oblique cuts, by varying
the
location and/or slope 962 of depression 958.
In a typical complete bypass procedure, for the heart, a graft is attached to
an aorta and
then to a coronary vessel. A similar procedure may be used in other blood
vessels, for example
the femoral artery. A punch mechanism 950 can be used for both blood vessels.
The graft may
be, for example, a vein or artery from the same or a different patient.
Alternatively, a xenograft
or a synthetic graft may be used instead.
The above description has focused on end-to-side anastomosis connectors.
However,
the above described features can also be applied to side-to-side and end-to-
end anastomosis
connections and connectors, for example replacing bending spikes with single
or double pivot
bending spikes. Additionally, the above described spike and ring segment
designs may also be
applied to hole closure devices, that radially contract and seal a hole formed
in a blood vessel.
Such devices may include only "forward" spikes, to engage the blood vessel, at
its side or at its
end.
It will be appreciated that the above described methods of vascular surgery
may be
varied in many ways, including, changing the order of steps, which steps are
performed inside
the body and which outside, the order of making the anastomosis connections,
the order of
steps inside each anastomosis, the exact materials used for the anastomotic
connectors and/or
which vessel is a "side" side and which vessel (or graft) is an "end" side of
an end-to-side



CA 02366708 2001-09-13
WO 00/56228 PCT/IB00/00310
anastomosis. Further, in the mechanical embodiments, the location of various
elements may be
switched, without exceeding the sprit of the disclosure, for example,
switching the anvil for the
cutting edge in the hole-punching devices and switching the moving elements
for non-moving
elements where relative motion is required. In addition, a multiplicity of
various features, both
of method and of devices have been described. It should be appreciated that
different features
may be combined in different ways. In particular, not all the features shown
above in a
particular embodiment are necessary in every similar preferred embodiment of
the invention.
Further, combinations of the above features are also considered to be within
the scope of some
preferred embodiments of the invention. In addition, some of the features of
the invention
described herein may be adapted for use with prior art devices, in accordance
with other
preferred embodiments of the invention. The particular geometric forms used to
illustrate the
invention should not be considered limiting the invention in its broadest
aspect to only those
forms, for example, where a circular lumen is shown, in other embodiments an
oval lumen
may be used.
Also within the scope of the invention are surgical kits which include sets of
medical
devices suitable for making a single or a small number of anastomosis
connections.
Measurements are provided to serve only as exemplary measurements for
particular cases, the
exact measurements applied will vary depending on the application. When used
in the
following claims, the terms "comprises", "comprising", "includes", "including"
or the like
means "including but not limited to".
It will be appreciated by a person skilled in the art that the present
invention is not
limited by what has thus far been described. Rather, the scope of the present
invention is
limited only by the following claims.
21

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date Unavailable
(86) PCT Filing Date 2000-03-20
(87) PCT Publication Date 2000-09-28
(85) National Entry 2001-09-13
Dead Application 2006-03-20

Abandonment History

Abandonment Date Reason Reinstatement Date
2005-03-21 FAILURE TO PAY APPLICATION MAINTENANCE FEE
2005-03-21 FAILURE TO REQUEST EXAMINATION

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Registration of a document - section 124 $100.00 2001-09-13
Application Fee $150.00 2001-09-13
Maintenance Fee - Application - New Act 2 2002-03-20 $50.00 2001-09-13
Maintenance Fee - Application - New Act 3 2003-03-20 $50.00 2003-03-20
Maintenance Fee - Application - New Act 4 2004-03-22 $100.00 2004-03-22
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
BY-PASS, INC.
Past Owners on Record
KEREN, DVIR
KILEMNIK, IDO
LOSHAKOVE, AMIR
ZIMET, NACHMAN
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Representative Drawing 2002-02-14 1 7
Description 2001-09-13 21 1,206
Cover Page 2002-02-15 1 38
Abstract 2001-09-13 1 61
Claims 2001-09-13 8 248
Drawings 2001-09-13 25 436
PCT 2001-09-13 10 381
Assignment 2001-09-13 4 143
Correspondence 2001-10-23 3 107
Correspondence 2002-02-19 1 25
Assignment 2001-09-13 6 225
Assignment 2002-03-28 8 323
Fees 2003-03-20 1 27
Fees 2004-03-22 1 25